# Sofamor Danek Mfg., Inc.

- Location (FDA's records): Memphis, TN
- FDA decisions: 23 (1992–1995): 23 510(k) clearances
- Product codes: KWP (10), KWQ (5), HRX (3), JDQ (2), LZN (1), MNH (1), HRS (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 25 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Buckman Co., Inc.: 5 (https://510kreport.com/company/buckman)
- K2m, Inc.: 3 (https://510kreport.com/company/k2m)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Spinal Concepts, Inc.: 2 (https://510kreport.com/company/spinal-concepts)
- Biomet Manufacturing Corp: 2 (https://510kreport.com/company/biomet-manufacturing)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)
- Spineology, Inc.: 1 (https://510kreport.com/company/spineology)
- Eminent Spine: 1 (https://510kreport.com/company/eminent-spine)

## Its most-cited devices
- K922543: Z-Plate Anterior Fixation System (1993), cited by 11
- K920201: Titanium Alloy Songer Cable System (1992), cited by 3
- K925812: Titanium Songer Cable System (1993), cited by 2
- K914306: TSRH (TM) Lateral Offset Plate (1992), cited by 1
- K923242: Crosslink Axial and Offset Plates (1993), cited by 1
- K922520: Modified TSRH Central Post Hooks (1992), cited by 1

## Recent decisions
- K936294: Sentry (TM) Anterior/Posterior Spinal Systems (Dec 19, 1995)
- K930191: Danek (TM) Spinal Epidural Endoscopic SY (Sep 26, 1995)
- K932029: TSRH Spinal Screws (Jan 20, 1995)
- K922486: Danek Tissue Cutting  and Removal System (Oct 12, 1993)
- K930710: Sentry Posterior Spinal System (Oct 1, 1993)
- K930807: Sentry Anterior Spinal System (Oct 1, 1993)
- K923242: Crosslink Axial and Offset Plates (May 19, 1993)
- K922543: Z-Plate Anterior Fixation System (May 19, 1993)

Source page: https://510kreport.com/company/sofamor-danek-mfg